Recon: Intercept to Seek Approval for NASH Drug After Mixed Phase III Results; Philippines Revokes License for Sanofi’s Dengvaxia

• Intercept's fatty liver drug meets late-stage main goal, shares soar (Reuters) (STAT) (Endpoints)
• Stealth player is poised to win a CRISPR patent that could speed the development of therapies (STAT)
• Here’s how prosecutors say generic drug makers schemed to fix prices (STAT)
• Throwing in the towel, troubled antibiotic maker Aradigm files for Chapter 11 (Endpoints) (Fierce)
• FDA approves pembrolizumab for adjuvant treatment of melanoma (FDA) (Press)
• FDA Cautions Over Young Donor Blood Transfusions to Treat Aging, Memory Loss (Focus) (STAT) (Press)
• Pfizer-Lilly drug shown to help reduce back pain in late-stage trial (Reuters)
• US top court rejects Maryland bid to revive drug price-gouging law (Reuters)
• The High Cost Of Sex: Insurers Often Don’t Pay For Drugs To Treat Problems (KHN)
• Judge rejects Goldwater effort to force disclosure of FDA access policy to life-saving drugs (Tuscon)

• Philippines revokes Sanofi's product license for dengue vaccine (Reuters)
• Ireland urges people not to stockpile medicines ahead of Brexit (Reuters)
• As medical costs mount, Japan to weigh cost-effectiveness in setting drug prices (Reuters)
• At last, a Brexit dividend – shame it’s for the pedlars of fake medicine (The Guardian)
• French biotech Inventiva’s lead drug stumbles in systemic sclerosis study, ahead of NASH readout (Endpoints)
• France Invites Advanced Therapy Makers To Use Fast-Track Trial Approval Pathway (Pink Sheet-$)
• Israel’s Immune Pharma waves the white flag after failing to secure deals for inflammation drug (Endpoints)
• Realm set to offload assets, leave London following failures (Fierce) (LSE)
• Gyroscope's gene therapy given to first dry AMD patient (PMLive) (PharmaTimes)
• ‘Inflexible’ NICE blocking access to rare disease drugs (PMLive) (PharmaTimes)
• China to establish national rare disease network (Pharmafile)
• Pfizer Receives European Approval For Zirabev, A Biosimilar To Avastin (Reuters) (Press)

• Unlocking the power of translational medicine (Nature)
• Insurers Are Not Paying Enough For HPV Vaccines -- And Our Kids Are Paying The Price (Forbes)
• Oral Insulin Delivery: Can the Tortoise Win the Race? (NIH)
• Ex-Celgene CEO Bob Hugin makes a leap back into biotech, joining an embattled Allergan’s board (Endpoints)
• Leave A Ladder Down (LifeSciVC)
• Vaccines don’t work against some viruses. CRISPR might one day fix that (STAT)
• Regenerative Medicines: FDA Finalizes Guidance on Expedited Programs (Focus)
• Drugmakers Seek More Clarity From FDA on Biomarkers With Multiple Applications (Focus)
• Industry, Advocacy Groups Seek Clarity on Proposed Changes to Informed Consent Rules (Focus)
• Teva aims for 25% of U.S. EpiPen market by 2020 (Drug Delivery)
• FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions (Focus)
• ‘Everyone is at fault’: With insulin prices skyrocketing, there’s plenty of blame to go around (STAT)
• Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation (Pink Sheet-$)
• Ochsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials (Press)
• ‘Off-the-shelf’ CAR-Ts have an important role to play – but are they ready for prime time? (MedCity)
• How One Biotech Venture Is Breaking The Cost Barrier In Manufacturing MAbs For Infectious Diseases (Pink Sheet-$)
• Arix reappoints CEO 5 months after starting hunt for replacement (Fierce)
• Novartis’ AveXis doubles down with $115M manufacturing investment (Fierce)
• CBER’s Learnings on Regenerative Medicine Development Reflected in Guidance Updates (FDA Law Blog)
• Pfizer dethrones AbbVie as Xeljanz soars past Humira in January TV spending (Fierce)
• Sage Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Highlights Pipeline and Business Progress (Press)

• As generic competition stutter sales of top oncology drugs, Roche secures speedy review for pair of experimental cancer offerings (Endpoints) (Press 1, 2)
• Xellia Pharmaceuticals Receives US FDA Approval for Premixed Vancomycin Injection (Press)
• Biohaven's Verdiperstat Receives Orphan Drug Designation From FDA For Multiple System Atrophy (Press)
• Dogged by safety issues, Eli Lilly and Pfizer tout their latest PhIII for anti-NGF pain drug tanezumab (Endpoints)
• ARS Pharmaceuticals Announces FDA Fast Track Designation for ARS-1 Intranasal Epinephrine Spray (Press)
• Astellas' Xtandi "significantly improves" progression-free survival in advanced hormone-sensitive prostate cancer (Pharmafile)
• Fusion Pharma Announces First Patient Dosing in a Phase 1 Clinical Trial of [225Ac]-FPI-1434 Injection in Patients with Advanced Solid Tumors (Press)
• Novus Therapeutics Doses First Patients in Phase 2a Trial of OP0201 (Press)

• Medtronic shares rise on FY2019 Q3 earnings beat (MassDevice) (Press)
• Medtronic wins FDA’s breakthrough status for closed-loop insulin system (MassDevice) (Press)
• Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis (Drug Delivery) (Press)
• Novo Nordisk's soon-to-be-released insulin pens will connect to Glooko's diasend platform (mobihealthnews)
• NuVasive wins FDA, CE Mark for Precice internal bone transport system (MassDevice)
• ReWalk Robotics files for exoskeleton suit clearance (MassDevice)
• Hancock Jaffe launches first-in-human VenoValve study (MassDevice)
• Axonics® Announces Positive Top-Line Clinical Data from its ARTISAN-SNM Pivotal Study (Press)

• A look inside Eric Hargan's calendar (Politico)
• President Trump's Plan To Stop HIV Faces A Tough Road In Oklahoma (NPR)
• In Arkansas, Thousands Of People Have Lost Medicaid Coverage Over New Work Rule (NPR)
• Medicare For All: Is The U.S. Headed In That Direction? (Forbes)
• Ohio seeks $16m from UnitedHealth’s PBM for overcharging on drugs (STAT)
• Another Wrinkle Removal Upheld (Drug & Device Law)

• FDA Advisory Committee Calendar

• Abbott to launch new production of hospital drugs in Russia this year (PharmaLetter-$)
• Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma (Focus)
• Accu-Chek® Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons (MHRA)
• EU ‘Big Data’ Report: Big Opportunities – And Big Challenges (PharmaLetter-$)
• "Game-changing" osteoarthritis drug receives £675k funding from Innovate UK (PharmaTimes)

• Asia Regulatory Roundup: TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda (Focus)
• China’s HaiHe Pharma sets up joint venture with CSPC (PharmaLetter)

• Income-Tax Department raids Divi's Lab premises (Economic Times)
• Doctors in Kashmir plan to boycott Macleods, Intas Pharma (Economic Times)
• Cipla to acquire 11.71% stake in Wellthy Therapeutics (Economic Times)

• Canada Steers Away From Using Suffixes in Biologics' Names (Focus)
• Summary Safety Review - Cough and cold products containing opioids (including codeine, hydrocodone or normethadone) (Health Canada)

• Companies Roll Out Gunshot Detectors at the Office (WSJ)
• Five Things I Wish I’d Known Before My Chronic Illness (NYTimes)
• In China, some parents seek an edge with genetic testing for tots (MIT Technology Review)